HB 371

1	A bill to be entitled
2	An act relating to the Cancer Drug Donation Program;
3	creating s. 381.94, F.S.; providing a short title;
4	creating the Cancer Drug Donation Program; providing a
5	purpose; providing definitions; providing conditions for
6	donation of cancer drugs and supplies to the program;
7	providing conditions for the acceptance of cancer drugs
8	and supplies into the program, inspection of cancer drugs
9	and supplies, and dispensation of cancer drugs and
10	supplies to eligible patients; requiring a physician's
11	office, pharmacy, hospital, hospice, or health care clinic
12	that accepts donated drugs and supplies through the
13	program to comply with certain state and federal laws;
14	authorizing a participating physician's office, pharmacy,
15	hospital, hospice, or health care clinic to charge fees
16	under certain conditions; requiring the Department of
17	Health, upon recommendation of the Board of Pharmacy, to
18	adopt certain rules; providing for the ineligibility of
19	certain persons to receive donated drugs; requiring the
20	department to establish and maintain a participant
21	registry; providing for the contents and availability of
22	the participant registry; providing immunity from civil
23	and criminal liability for donors, program participants,
24	or pharmaceutical manufacturers in certain circumstances;
25	providing an effective date.
26
27	Be It Enacted by the Legislature of the State of Florida:
28
29	Section 1.  Section 381.94, Florida Statutes, is created to
30	read:
31	381.94  Cancer Drug Donation Program.--
32	(1)  This act may be cited as the "Cancer Drug Donation
33	Program Act."
34	(2)  There is created a Cancer Drug Donation Program within
35	the Department of Health for the purpose of authorizing and
36	facilitating the donation of cancer drugs and supplies to
37	eligible patients.
38	(3)  As used in this section:
39	(a)  "Cancer drug" means a prescription drug used to treat
40	cancer or its side effects or used to treat the side effects of
41	a prescription drug used to treat cancer or its side effects.
42	(b)  "Department" means the Department of Health.
43	(c)  "Donor" means a person, health care facility,
44	hospital, pharmacy, drug manufacturer, medical device
45	manufacturer or supplier, wholesaler of drugs or supplies, or
46	any other entity that donates cancer drugs, or supplies needed
47	to administer such drugs, in accordance with this section.
48	(d)  "Eligible patient" means a person who the department
49	determines is eligible to receive cancer drugs from the program.
50	(e)  "Health care facility" means a health care facility
51	licensed under chapter 395.
52	(f)  "Health care clinic" means a health care clinic
53	licensed under part XIII of chapter 400.
54	(g)  "Hospice" means a corporation licensed under part VI
55	of chapter 400.
56	(h)  "Hospital" means a facility as defined in s. 395.002
57	and licensed under chapter 395.
58	(i)  "Participant" means a physician's office, pharmacy,
59	hospital, hospice, or health care clinic that has elected to
60	participate in the program and that accepts donated cancer drugs
61	and supplies under the rules adopted by the department for the
62	program.
63	(j)  "Pharmacist" means a pharmacist licensed under chapter
64	465.
65	(k)  "Pharmacy" means an entity licensed under chapter 465.
66	(l)  "Physician's office" means the office of a person
67	licensed to practice medicine under chapter 458 or osteopathic
68	medicine under chapter 459.
69	(m)  "Prescribing practitioner" means a physician licensed
70	under chapter 458 or any other medical professional with
71	authority under state law to prescribe cancer medication.
72	(n)  "Prescription drug" means a drug as defined in s.
73	465.003(8).
74	(o)  "Program" means the Cancer Drug Donation Program
75	created by this section.
76	(p)  "Supplies" means any supplies used in the
77	administration of a cancer drug.
78	(4)  Any person or entity may donate cancer drugs or
79	supplies to the program. Cancer drugs or supplies may be donated
80	at a physician's office, pharmacy, hospital, hospice, or health
81	care clinic that elects to participate in the program and meets
82	criteria established by the department for such participation.
83	Cancer drugs or supplies may not be donated to a specific cancer
84	patient, and donated drugs or supplies may not be resold by the
85	program.
86	(5)  The cancer drug or supplies donated to the program may
87	be prescribed only by a prescribing practitioner for use by an
88	eligible patient and may be dispensed only by a pharmacist.
89	(6)(a)  A cancer drug may only be accepted or dispensed
90	under the program if such drug is in its original, unopened,
91	sealed, and tamper-evident unit dose packaging, except that a
92	cancer drug packaged in single unit doses may be accepted and
93	dispensed if the outside packaging is opened but the single-
94	unit-dose packaging is unopened.
95	(b)  A cancer drug may not be accepted or dispensed under
96	the program if such drug bears an expiration date that is less
97	than 6 months after the date the drug was donated or if the drug
98	is adulterated or misbranded as determined in paragraph (c).
99	(c)  Prior to being dispensed to an eligible patient, the
100	cancer drug or supplies donated under the program shall be
101	inspected by a pharmacist to determine that the drug and
102	supplies are not adulterated or misbranded.
103	(d)  A dispenser of donated cancer drugs or supplies may
104	not submit a claim or otherwise seek reimbursement from any
105	public or private third-party payor for donated cancer drugs or
106	supplies dispensed to any patient under the program, and a
107	public or private third-party payor is not required to provide
108	reimbursement to a dispenser for donated cancer drugs or
109	supplies dispensed to any patient under the program.
110	(7)(a)  A physician's office, pharmacy, hospital, hospice,
111	or health care clinic that accepts donated cancer drugs or
112	supplies under the program shall comply with all applicable
113	provisions of state and federal law relating to the storage,
114	distribution, and dispensing of the donated cancer drugs or
115	supplies.
116	(b)  A physician's office, pharmacy, hospital, hospice, or
117	health clinic that participates in the program may charge a
118	nominal handling fee for distributing or dispensing cancer drugs
119	or supplies under the program. The fee shall be established in
120	rules adopted by the department.
121	(8)  The department, upon the recommendation of the Board
122	of Pharmacy, shall adopt rules to carry out the provisions of
123	this section. Initial rules under this section shall be adopted
124	no later than 90 days after the effective date of this act. The
125	rules shall include, but not be limited to:
126	(a)  Eligibility criteria, including a method to determine
127	priority of eligible patients under the program.
128	(b)  Standards and procedures for participants that accept,
129	store, distribute, or dispense donated cancer drugs or supplies.
130	(c)  Necessary forms for administration of the program,
131	including, but not limited to, forms for use by persons or
132	entities that donate, accept, distribute, or dispense cancer
133	drugs or supplies under the program.
134	(d)  The maximum handling fee that may be charged by a
135	participant that accepts and distributes or dispenses donated
136	cancer drugs or supplies.
137	(e)  Categories of cancer drugs and supplies that the
138	program will accept for dispensing.
139	(f)  Categories of cancer drugs and supplies that the
140	program will not accept for dispensing and the reason that such
141	drugs and supplies will not be accepted.
142	(g)  Maintenance and distribution of the participant
143	registry established in subsection (10).
144	(9)  A person who is eligible to receive cancer drugs or
145	supplies under the state Medicaid program or under any other
146	prescription drug program funded in whole or in part by the
147	state is ineligible to participate in the program created under
148	this section.
149	(10)  The department shall establish and maintain a
150	participant registry for the program. The participant registry
151	shall include the participant's name, address, and telephone
152	number and shall identify whether the participant is a
153	physician's office, pharmacy, hospital, hospice, or health care
154	clinic. The department shall make the participant registry
155	available to any person or entity wishing to donate cancer drugs
156	or supplies to the program.
157	(11)  Any donor of cancer drugs or supplies, or any
158	participant in the program, who exercises reasonable care in
159	donating, accepting, distributing, or dispensing cancer drugs or
160	supplies under the program and the rules adopted under this
161	section shall be immune from civil or criminal liability and
162	from professional disciplinary action of any kind for any
163	injury, death, or loss to person or property relating to such
164	activities.
165	(12)  A pharmaceutical manufacturer is not liable for any
166	claim or injury arising from the transfer of any cancer drug
167	under this section, including, but not limited to, liability for
168	failure to transfer or communicate product or consumer
169	information regarding the transferred drug, as well as the
170	expiration date of the transferred drug.
171	Section 2.  This act shall take effect July 1, 2006.

CODING: Words stricken are deletions; words underlined are additions.